Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the recommended phase 2 dose and overall safety and tolerability of TRC105 when given in combination with capecitabine for the treatment of patients with progressive or recurrent metastatic breast cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tracon Pharmaceuticals Inc.
• Collaborators: Roswell Park Cancer Institute; United States Department of Defense
• Treatments: Antibodies, Monoclonal; Capecitabine

Criteria

Inclusion Criteria:

• Histologically proven advanced solid cancer for which curative therapy is not available (Part 1 only)

• Histologically proven metastatic Her-2-negative breast cancer (Part 2 only)

• Measurable disease by RECIST 1.1 criteria (Part 2 only)

• Willing and able to consent for self to participate in study

• Progressive or recurrent disease after prior systemic chemotherapy regimen

• Age ≥ 18 years

• ECOG performance status of 0 or 1

• Resolution of all acute toxic effects of prior therapy to NCI CTCAE Grade ≤ 1 or baseline (except alopecia)

• Adequate organ function

Exclusion Criteria:

• Prior treatment with more than one systemic chemotherapy regimen for metastatic disease.

• Prior treatment with TRC105

• History of hypersensitivity reaction to antimetabolite therapy

• Receipt of an investigational agent within 28 days of starting study treatment

• Prior surgery (including open biopsy), radiation therapy or systemic therapy within 28 days of starting study treatment

• Minor surgical procedures within 14 days prior to first dose of TRC105

• History of brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease

• Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months

• Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite optimal therapy

• Past medical history of acquired or inherited coagulopathy including patients with known hereditary hemorrhagic telangiectasia

• Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first dose with TRC105

• Cardiac dysrhythmias of NCI CTCAE Grade ≥ 2 within the last month

• Hemorrhage within 28 days of starting study treatment

• Unhealed wounds within 28 days of starting study treatment

• History of peptic ulcer disease or gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment

• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness

• Known active viral or nonviral hepatitis

• History of hypersensitivity reaction to human or mouse antibody products

• Lung cancer with central chest lesions

• Pregnancy or breastfeeding